This is so typical

This is so typical

Today GlaxoSmithKline (NYSE:GSK) is running ads in major newspapers around the country touting the safety of Avandia. These ads come just one day after the FDA announced the formation of a new panel which is supposed to educate consumers about the risks of using drugs. The new Risk Communication Advisory Committee will be consists of 15 experts and patient advocates. The timing of the FDA’s announcement is interesting since it comes just two days before the House Oversight Committee hearings on Avandia.

To Diabetic Investor these events are just further evidence that the government has no clue how to handle the Avandia situation and the role the FDA plays. Looking over the witness list for tomorrow’s hearings all the parties involved will have their opportunity to explain their side of the story. Andrew C. von Eschenbach, M.D., Commissioner of the FDA will surly tout the formation of this new panel as a necessary first step towards better patient education. It’s also likely he’ll claim that is the just the first of many steps the FDA will take to insure the drugs Americans take are safe and effective. Also appearing will be Steven Nissen, M.D whose meta-analysis of Avandia data created the controversy. Look for Dr. Nissen to stand by his analysis and ask the government not to wait until the RECORD study is completed in 2009 to make a decision on Avandia. (RECORD is a 4,400-patient, eight-year clinical trial which is designed to look for cardiovascular outcomes in Avandia.) Moncef Slaoui, Glaxo’s Chairman, Research and Development, will state that Glaxo’s first and most important concern is that patients have all the facts and seek the guidance of their physician before making any therapy changes. He will go onto to state that Glaxo stands by Avandia and the results of RECORD will vindicate the drug.

When it’s all said and done everyone will claim victory. This will be followed by a universal chorus that the real winners were the patients. Sadly this will not be the case as patients are more confused then ever when it comes to what to do with Avandia. As the medical community is taking up sides, the patient is left wondering is Avandia really safe. It’s doubtful they will find much comfort that the RECORD data which is two years away should clear up everything. What happens if the RECORD data indicates that the concern over Avandia is valid? Patients want answers yesterday not two years from today. Diabetic Investor believes the FDA would be setting a dangerous precedent if they wait for RECORD to be completed. Following this path basically puts the risk of taking Avandia back on the patient and their physician, hardly an improvement over the current situation.

Diabetic Investor would find greater comfort in this path if Avandia was the only effective medication for treating type 2 diabetes, but this is not the case. There are other medications available which gives the FDA several other options. While Glaxo would not be happy with a “black box” warning the FDA can easily justify such a move citing that until the RECORD data is available patient safety is their paramount concern. Since there is a divided opinion on Avandia’s safety the prudent move is to take all necessary precautions until definitive data is available. Should it turn out RECORD vindicates Avandia the agency can always remove the warning.

Regardless of what happens with Avandia there is a much bigger issue here. Why two years after Vioxx are we once again facing a similar situation with Avandia? Did the FDA learn nothing from Vioxx? There is no question that the drug approval process is already complex and expensive. However, how many lives must be lost before the FDA realizes that it’s time for reform? Diabetes is not going away and the patient population will only get larger. Millions of Americans want to know that the drugs they take each and every day are safe. They also understand there are no guarantees and it’s next to impossible to accurately predict the long term effects of any medication. Still the drug approval must be reformed; Rezulin, Vioxx and now Avandia make this abundantly clear.

Diabetic Investor is by no means advocating a move back to the days when it took forever to bring new medications to market. Our proposal is simple; for disease states such as diabetes where there are several safe and effective medications already available set a higher threshold for new drugs. New drugs should do more than match the performance of existing medications they should exceed what’s already available. This may slow down the approval process for new drugs somewhat yet no harm is being done as patients already have safe and effective options available. When it comes to new medications the FDA should follow one of the oldest rules around, better safe than sorry.

David Kliff
Diabetic Investor
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